Publications by authors named "Katherine Fleming-Dutra"
During 2023, the Centers for Disease Control and Prevention (CDC) recommended the first respiratory syncytial virus (RSV) immunizations intended for widespread use in the United States to prevent severe RSV illness in infants and older adults. CDC, in collaboration with federal, public health, and academic partners, is conducting evaluations of real-world effectiveness of recommended RSV immunization products in the United States. Similar frameworks for evaluation are being applied to RSV vaccines and nirsevimab, a long-acting preventative monoclonal antibody, to estimate product effectiveness.
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- Respiratory syncytial virus (RSV) leads to significant hospitalizations in infants in the US, prompting recommendations for nirsevimab to prevent RSV in all infants under 8 months and at-risk children up to 19 months during their RSV seasons.* -
- A simulation study found that administering nirsevimab could potentially avoid over 107,000 outpatient visits and 14,000 hospitalizations annually if half of newborns receive it, costing approximately $153,517 per quality-adjusted life year (QALY) saved.* -
- The analysis suggests nirsevimab is cost-effective, particularly for high-risk infants, though the cost-per-QALY can vary widely based on factors like hospitalization costs
Background And Objectives: Respiratory syncytial virus (RSV) commonly causes hospitalization among US infants. A maternal vaccine preventing RSV in infants, RSV bivalent prefusion F maternal vaccine (RSVpreF), was approved by the US Food and Drug Administration and recommended by the Advisory Committee on Immunization Practices. Our objective was to evaluate the health benefits and cost-effectiveness of vaccinating pregnant persons in the United States using RSVpreF.
View Article and Find Full Text PDFEffectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection-Increasing Community Access to Testing Program, United States, January-September 2023.
Influenza Other Respir Viruses
November 2024
Background: On September 2, 2022, bivalent COVID-19 mRNA vaccines, were recommended to address reduced effectiveness of COVID-19 monovalent vaccines during SARS-CoV-2 Omicron variant predominance.
Methods: Using national pharmacy-based SARS-CoV-2 testing program data from January 15 to September 11, 2023, this test-negative, case-control design study assessed bivalent COVID-19 vaccine effectiveness (VE) against symptomatic infection.
Results: VE against symptomatic infection of a bivalent dose between 2 weeks and 1 month after bivalent vaccination ranged from 46% (95% CI: 38%-52%) for those aged ≥ 65 years to 61% (95% CI 41%-75%) for those aged 12-17 years.
Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: a test-negative design analysis.
Amanda B Payne Janet A Watts Patrick K Mitchell Kristin Dascomb Stephanie A Irving Katherine E Fleming-Dutra
Lancet
October 2024
Background: Respiratory syncytial virus vaccines first recommended for use during 2023 were efficacious against lower respiratory tract disease in clinical trials. Limited real-world data regarding respiratory syncytial virus vaccine effectiveness are available. To inform vaccine policy and address gaps in evidence from the clinical trials, we aimed to assess the effectiveness against respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years.
View Article and Find Full Text PDFUse of COVID-19 Vaccines for Persons Aged ≥6 Months: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024-2025.
Lakshmi Panagiotakopoulos Danielle L Moulia Monica Godfrey Ruth Link-Gelles Lauren Roper Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
September 2024
Article Synopsis
- COVID-19 vaccinations, particularly the newly recommended monovalent XBB.1-strain vaccines for all individuals 6 months and older, are vital for protection against severe illness and death from COVID-19, especially as new strains like Omicron JN.1 and KP.2 are spreading in the U.S.! -
- As vaccine effectiveness decreases over time, the ACIP has advised that everyone 6 months and older should receive the 2024-2025 COVID-19 vaccines, which have been approved or authorized by the FDA, including those from Moderna and Pfizer-BioNTech for ages 12 and up, and under Emergency Use Authorization for younger children!* -
- The FDA also authorized Novava
Effectiveness of the Original Monovalent and Bivalent COVID-19 Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters in Pregnant Persons Who Were Not Immunocompromised: VISION Network, June 2022-August 2023.
Allison Avrich Ciesla Victoria Lazariu Kristin Dascomb Stephanie A Irving Brian E Dixon Katherine E Fleming-Dutra
Open Forum Infect Dis
September 2024
Article Synopsis
- Pregnant individuals are at a higher risk for severe COVID-19, leading to current guidelines recommending updated vaccinations for everyone aged 6 months and older, regardless of pregnancy status.
- A study evaluated COVID-19 vaccine effectiveness among pregnant people aged 18 to 45 from June 2022 to August 2023, finding that vaccine effectiveness during pregnancy was 52%, compared to 28% when vaccination was received less than 6 months before pregnancy and only 6% when received more than 6 months prior.
- The findings suggest that pregnant individuals should remain up-to-date with recommended COVID-19 vaccinations for better protection against the virus.
Article Synopsis
- Respiratory syncytial virus (RSV) is a significant cause of respiratory issues and hospitalizations in older adults during fall and winter in the U.S., prompting new vaccination recommendations.
- For the 2023-2024 season, a single dose of FDA-approved RSV vaccines is now recommended for all adults aged 75 and older, and for those aged 60-74 who are at higher risk for severe RSV.
- The updated guidelines aim to improve vaccination rates among high-risk groups and include ongoing monitoring of vaccine effectiveness and safety to inform future decisions.
Use of an Additional Updated 2023-2024 COVID-19 Vaccine Dose for Adults Aged ≥65 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024.
Lakshmi Panagiotakopoulos Monica Godfrey Danielle L Moulia Ruth Link-Gelles Christopher A Taylor Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
April 2024
Article Synopsis
- - COVID-19 is still a significant public health concern, especially for individuals aged 65 and older, who accounted for 67% of COVID-19-related hospitalizations from October 2023 to January 2024.
- - The CDC recommended that everyone aged 6 months and older receive the updated 2023-2024 COVID-19 vaccine to protect against severe illness, as the virus continues to circulate and variants are emerging.
- - Additionally, on February 28, 2024, it was advised that those aged 65 and older get an extra dose of the updated vaccine to boost their immunity and reduce the risk of severe outcomes, including death.
Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19-Associated Hospitalization Among Adults Aged ≥18 Years with Immunocompromising Conditions - VISION Network, September 2023-February 2024.
Ruth Link-Gelles Elizabeth A K Rowley Malini B DeSilva Kristin Dascomb Stephanie A Irving Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
March 2024
Article Synopsis
- The CDC recommended the updated 2023-2024 COVID-19 vaccination (monovalent XBB.1.5) for everyone aged 6 months and older to help prevent severe disease caused by COVID-19.
- For individuals with immunocompromising conditions, additional vaccine doses may be needed due to their increased risk of severe illness and potentially weaker vaccine responses.
- Vaccine effectiveness for the updated dose was about 38% for hospitalized adults with immunocompromising conditions 7-59 days post-vaccination and 34% between 60-119 days, but only 18% of this high-risk group had received the updated vaccine.
Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalization Among Immunocompetent Adults Aged ≥18 Years - VISION and IVY Networks, September 2023-January 2024.
Jennifer DeCuir Amanda B Payne Wesley H Self Elizabeth A K Rowley Kristin Dascomb Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
February 2024
Article Synopsis
- In September 2023, the CDC recommended the updated 2023-2024 monovalent XBB.1.5 COVID-19 vaccine for everyone aged 6 months and older to help prevent COVID-19, including severe cases.
- An analysis of vaccine effectiveness (VE) found that during the first 59 days after vaccination, the VE against COVID-19-related emergency department visits was 51%, which dropped to 39% after 60-119 days.
- The updated COVID-19 vaccine showed increased protection, with VE against hospitalizations being 52% and 43% between two networks, supporting CDC's guidelines for vaccination.
The GSK and Pfizer respiratory syncytial virus (RSV) vaccines are both indicated for adults aged 60 years and older, but only the Pfizer product is approved for use in pregnancy to prevent RSV-associated lower respiratory tract disease in infants aged younger than 6 months. To assess for vaccine administration errors (ie, administration of the GSK RSV vaccine to pregnant persons) VAERS (Vaccine Adverse Event Reporting System), a U.S.
View Article and Find Full Text PDFEarly Estimates of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Attributable to Co-Circulating Omicron Variants Among Immunocompetent Adults - Increasing Community Access to Testing Program, United States, September 2023-January 2024.
Ruth Link-Gelles Allison Avrich Ciesla Josephine Mak Joseph D Miller Benjamin J Silk Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
February 2024
Article Synopsis
- - The CDC recommended an updated COVID-19 vaccine derived from the XBB.1.5 variant for everyone aged 6 months and older to protect against COVID-19, as new variants like JN.1 emerged and spread in fall 2023.
- - Research analyzed over 9,000 tests, finding that the vaccine effectiveness was about 54% for adults 18 and older, with variations depending on testing methods and timing post-vaccination.
- - The updated vaccines are effective in protecting against symptomatic infections, and the CDC will keep monitoring their effectiveness, urging all eligible individuals to get vaccinated.
Article Synopsis
- - COVID-19 vaccines have been a significant success in reducing hospitalizations and deaths in the U.S., with over 675 million doses given and over 80% of the population receiving at least one dose.
- - The vaccines are estimated to have prevented more than 18 million hospitalizations and 3 million deaths, despite over one million fatalities from COVID-19 during the pandemic.
- - The Advisory Committee on Immunization Practices (ACIP) has actively reviewed data and made recommendations on COVID-19 vaccines, emphasizing their safety and effectiveness as key tools in combating serious illness from the virus.
Article Synopsis
- A study analyzed the clinical characteristics and vaccination status of young children hospitalized for acute COVID-19 across 28 pediatric hospitals in the U.S. from September 2022 to May 2023.
- Of the 597 children examined, only 4.5% had completed their primary COVID-19 vaccination series, while 7.0% had started but not completed it, with the majority being unvaccinated.
- Most children admitted with severe COVID-19, including those requiring intensive care, were previously healthy and had not initiated vaccination, highlighting a concerning gap in immunization among vaccine-eligible young kids.
COVID-19 vaccines were originally authorized in the United States in December 2020 on the basis of safety, immunogenicity, and clinical efficacy data from randomized controlled trials (RCTs). However, real-world vaccine effectiveness (VE) data are necessary to provide information on how the vaccines work in populations not included in the RCTs (e.g.
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- * A case-control study involving 3,647 healthcare personnel showed that bivalent vaccine effectiveness (VE) was about 34.1%, with the highest effectiveness (54.8%) observed shortly after administration, declining as time passed.
- * The study highlights that while bivalent doses initially provide substantial protection against COVID-19, their effectiveness significantly wanes after two months, suggesting the need for ongoing monitoring and potential updates to vaccination strategies.
Article Synopsis
- The study aimed to investigate how a COVID-19 diagnosis at delivery affects maternal health and pregnancy outcomes during the dominance of different variants: pre-Delta, Delta, and Omicron.
- Using data from nearly 3 million delivery hospitalizations, researchers found that 1.9% of women had COVID-19 at the time of delivery, with a significant number during the Omicron period.
- Results indicated that pregnant women with COVID-19 experienced higher risks of severe complications such as maternal sepsis, acute respiratory distress syndrome, and in-hospital death, especially during the Omicron variant prevalence.
Article Synopsis
- Infants under 6 months are not eligible for COVID-19 vaccines, but maternal vaccination during pregnancy can help protect these infants from being hospitalized due to COVID-19.
- A study found that vaccinated mothers showed a 35% effectiveness in preventing COVID-19-related hospitalizations in infants under 6 months and 54% for those under 3 months.
- Vaccinated mothers had lower rates of severe outcomes for their infants, such as intensive care unit admissions and the need for mechanical ventilation, highlighting the importance of vaccination for expectant mothers.*
Use of Updated COVID-19 Vaccines 2023-2024 Formula for Persons Aged ≥6 Months: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2023.
Joanna J Regan Danielle L Moulia Ruth Link-Gelles Monica Godfrey Josephine Mak Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
October 2023
Article Synopsis
- COVID-19 vaccines are crucial for preventing severe outcomes, like hospitalization and death, but their effectiveness has been impacted by evolving variants.
- Since September 2022, bivalent mRNA vaccines were recommended, but they were tailored to variants that are no longer prevalent.
- As of September and October 2023, the FDA approved updated vaccines from Moderna, Pfizer-BioNTech, and Novavax to enhance immunity against currently circulating variants, with vaccination recommended for everyone aged 6 months and older.
Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023.
MMWR Morb Mortal Wkly Rep
October 2023
Article Synopsis
- Respiratory syncytial virus (RSV) is a major cause of hospitalization for infants in the U.S., leading to recommended preventative measures like nirsevimab (Bevfortus) for infants and the newly approved RSVpreF vaccine (Abrysvo) for pregnant individuals.
- The FDA approved the RSVpreF vaccine in August 2023 for administration during weeks 32-36 of pregnancy to help protect infants under 6 months from RSV-related respiratory issues.
- The CDC's Advisory Committee on Immunization Practices recommends that either the RSVpreF vaccine for mothers or nirsevimab for infants be used to protect against RSV, but not necessarily both for most infants.
Article Synopsis
- Protection against COVID-19 is crucial for healthcare workers, especially as vaccine effectiveness has decreased with the rise of the Omicron variant.
- A study evaluated the effectiveness of a monovalent mRNA booster dose from October 2021 to June 2022, finding that its effectiveness dropped significantly from 86% during Delta prevalence to 65% during Omicron prevalence.
- The results indicated that while a booster dose provides strong protection initially, its effectiveness wanes over time, dropping to 32% at least 120 days after vaccination, highlighting the importance of staying current with COVID-19 vaccinations.
Article Synopsis
- - Respiratory syncytial virus (RSV) is the top reason for hospitalizations in U.S. infants, and in July 2023, the FDA approved a new treatment called nirsevimab to help prevent RSV-related lung infections in infants and young kids.
- - The ACIP has been reviewing nirsevimab's safety and effectiveness since October 2021, and in August 2023, recommended it for all infants under 8 months in their first RSV season and for at-risk children up to 19 months entering their second season.
- - Nirsevimab is expected to be given mainly from October to March, based on RSV patterns from before the COVID-19 pandemic, and it can significantly
Effectiveness of Monovalent and Bivalent mRNA Vaccines in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters Among Children Aged 6 Months-5 Years - VISION Network, United States, July 2022-June 2023.
Ruth Link-Gelles Allison Avrich Ciesla Elizabeth A K Rowley Nicola P Klein Allison L Naleway Katherine E Fleming-Dutra
MMWR Morb Mortal Wkly Rep
August 2023
Article Synopsis
- - On June 19, 2022, the FDA approved mRNA COVID-19 vaccines for young children based on safety and efficacy data from trials, with Pfizer-BioNTech for ages 6 months-4 years and Moderna for ages 6 months-5 years.
- - The CDC updated vaccine recommendations on December 9, 2022, including the use of bivalent vaccines for children aged 6 months and older, after assessing their effectiveness against hospital visits for COVID-19-like illness.
- - Effectiveness of two Moderna doses was found to be 29%, while three Pfizer doses showed 43% effectiveness; however, children who received at least one bivalent dose had an 80% effectiveness in preventing